I. Field of the Invention
The present invention relates generally to pharmaceutical formulations and methods of using the same. More particularly, methods for rapidly treating moderate to severe hypoglycemia in emergency situations or preventing such situations from occurring.
II. Description of the Related Art
Recurrent episodes of severe hypoglycemia not only adversely impacts the quality of life for patients, but also, when severe, can cause seizures, coma, and even death. Severe hypoglycemia is defined as an episode of hypoglycemia that the patient cannot self-treat so that external help is required. Typically, neuroglycopenic symptoms and cognitive impairment begin at a blood glucose level of about 50 mg/dL (2.8 mmol/L), and include cognitive dysfunction that presents as confusion, a slowing of reflexes, the loss of the ability to comprehend and act appropriately, and unpredictable and combative behavior. A blood glucose level below 30 mg/dL may lead to seizures, coma, and death. The seriousness of the situation requires a treatment that responds rapidly, i.e., within 1 to 5 minutes, to prevent the level from falling too far.
Glucagon is a naturally occurring peptide hormone that is 29 amino acids in length and is secreted by the cells of the pancreas. The principal function of glucagon is to maintain glucose production through both glycogenolysis and gluconeogenesis, mostly mediated via the liver. Glucagon is the primary counter-regulatory hormone to insulin and is used as a first-line treatment of hypoglycemia in patients, and particularly those with diabetes. For patients with current or impending hypoglycemia, it is essential to have a treatment that is rapid and easy to administer in an emergency situation or to prevent such an emergency situation from occurring.
Although some progress has been made, there still remains a need for a more user friendly glucagon rescue medication for rapidly treating ongoing or impending hypoglycemia.